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Genetic Signatures Receives TGA Approval to Market Superbug Detection Kits in Australia

Molecular diagnostics company Genetic Signatures has received Therapeutic Goods Administration (TGA) registration, thereby allowing the sale of its novel “Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms” (ESBL & CPO) detection kit in Australia.

This follows the company’s receipt of European approval last month which enabled the sale of the ESBL & CPO products across Europe.

The company’s tongue-twistingly-named product detects hospital ‘superbugs’ and ‘antibiotic-resistant’ pathogens in under 3 hours.

Today’s news means Genetic Signatures can now sell its EasyScreen ESBL & CPO detection kits across Australia in addition to its existing set of TGA-registered products based on its EasyScreen platform, underpinned by “3base multiplex technology”.

Genetic Signatures says that at the current time, its key target markets are major hospital and pathology laboratories undertaking infectious disease screening, although this could potentially change dependent upon market demand and the future prevalence of antibiotic-resistant superbugs.

Superbugs have quickly become a significant global concern for healthcare professionals around the world. “Superbug” is a term that’s been coined to describe strains of bacteria that are resistant to commonly-used antibiotics.

Resistant bacteria that cause pneumonia, urinary tract infections and skin infections are just a few of the effects of such so-called superbugs that have become a worrying problem for hospitals.

Fighting superbugs starts with detection

Genetic Signatures designs and manufactures a suite of real-time Polymerase Chain Reaction (PCR) based products for the routine detection of infectious diseases under its proprietary EasyScreen brand.

Its MDx 3base technology provides high-volume hospital and pathology laboratories with the ability to screen for a wide array of infectious pathogens, with a high degree of specificity and greatly improved time horizon.

According to a study by the Rand Corporation in 2014, the estimated global cost of antimicrobial resistance is approximately US$95 billion per year (and growing) over the next 20 years.

Given standard treatments may be rendered ineffective against superbugs, rapid identification of infected patients is important, so they can be isolated and treated before the infection spreads.

The company said its EasyScreen ESBL & CPO Kit allows for rapid detection in less than 3 hours with “minimal hands-on time” for laboratory technicians.

The detection kit has been designed to provide rapid and accurate detection of 16 Beta-lactam and Carbapenem-resistant pathogen targets and is therefore able to identify a larger number of pathogen targets in a shorter time frame than conventional methods.

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